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2013 National Rx Drug Abuse Summit

Remarks by Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
2013 National Rx Drug Abuse Summit
Champions Gate, Florida
April 2, 2013

Thank you Dr. Dupont for your kind introduction and your remarkable leadership over so many years in science and policy. I'm pleased and honored to be part of this important summit. We are gathered here this morning in sunny Orlando to address a topic that, sadly, has cast a terrible shadow across our nation...a public health crisis of enormous — and devastating proportion. This crisis has affected us all, and meaningful and enduring solutions will require all of our collective efforts.

Congressman Rogers, you are to be congratulated for having the vision to found a nonprofit organization ten years ago to combat prescription drug abuse in Southern and Eastern Kentucky. Not only did you create Operation UNITE but you had the vision to appoint the extraordinary and energetic Karen Kelly as its president as well! And now you have brought this vision of a multi-pronged strategy — treatment, law enforcement investigations and community education starting local — to the national stage.

Certainly, the many stakeholders who have gathered for this three-day summit demonstrate the depth and the breadth of our national concern about the epidemic of misuse, abuse and diversion of prescription drugs, especially prescription opioids, in the United States.

I know that my colleague, Dr. Frieden, will be talking later about some of the numbers. But according to the latest data from the CDC, inappropriate use of prescription opioid drugs in the U.S. in 2010 led to an estimated 16,650 deaths, a 313 percent increase over the past decade. And for each death, there are an additional ten treatment admissions, 32 emergency department visits, and 825 nonmedical users of these drugs. While much of the problem is attributable to illicit use which can include sharing medication with family and friends or theft of the drug from home medicine cabinets, legitimate use of medications for pain may also lead to unnecessary adverse events, addiction, and death for some patients.

Indeed, look beyond these grim statistics and you will find individuals and their families whose lives have been shattered by prescription opioid abuse misuse and addiction. I suspect that all of us have a relative, a friend, a colleague who has been directly — and tragically — affected by this problem. None of us, on a personal level, is immune...no matter who you are, where you live, how well-educated you are, or how much money you make. All of us need to care...and all of us need to act...and act now.

As public health professionals, we not only must track the numbers and study the science, we must never forget the human dimension. And it is a powerful reminder of the importance and urgency of the tasks before us.

We have met with many of these devastated families. They have shared their memories and their photos of happier times, and far too often the stories they tell follow the same sad arc. We've heard, for example, about older relatives who accidentally take too large a dose, or the teenager or young adult who is prescribed an opioid following an accident, only to wind up on a path of addiction that results in their death.

In recent years, an impassioned, sometimes heated, debate has occurred, within and across many communities. Policy-makers, patients, families, law enforcement agents, educators and, of course, the medical and health policy communities and others, are immersed in discussions about the best ways to ensure that opioids are used appropriately, while working to prevent any further tragedies. And FDA is in the thick of these debates. We play a critical role in the development, review and approval of drugs, in reviewing scientific data to assure accurate drug prescribing information, and in monitoring the safety, efficacy and quality of drugs throughout their lifecycle, even after approval. We monitor how these products are used by patients to determine whether certain drugs should remain on the market as circumstances change over time.

Throughout this process, we must strike a balance between the risks associated with misuse, abuse and addiction and the potential benefits of these products in helping patients who have pain.

In doing so, we also recognize there can be multiple ways of treating pain, involving both prescription and over-the-counter drugs, with opioids as only one of these options. All available drugs — even aspirin — have their challenges, but opioid drugs require our special attention and concern.

Just as we've talked to those whose lives have been shattered by the abuse and misuse of opioids, we've also heard from prescribers and their patients who live every day with intense, serious pain. They include patients wracked with pain from a host of ailments, and for whom opioids offer some hope for their quality of daily life. They worry that their treatment options could be taken away.

When it comes to opioids, FDA can and does require that drug manufacturers take measures to better ensure the safety — and safe use — of their products. That may include providing education materials to patients and providers, appropriate formulations, and labeling...but all of these areas require continuing focus and action.

FDA has another important task: we advise the Drug Enforcement Administration on questions surrounding the ranking or scheduling of drugs on the DEA's controlled substances list. The closed distribution system ranks scheduled drugs into five categories based on their potential for abuse. DEA is responsible for scheduling drugs and registering health care professionals who prescribe controlled substances and the dispensers, drug manufacturers and distributors who supply these drugs.

FDA is currently working on DEA's request for a scientific and medical evaluation and scheduling recommendation on drugs containing hydrocodone, either combined with other analgesics such as acetaminophen or for cough suppression in combination with other cough-cold substances. We recently convened a two-day advisory committee meeting with experts on this subject and are reviewing their advice as we prepare our recommendations to DEA.

I've talked about FDA's authority and responsibilities when it comes to prescription painkillers. But it is also important to recognize some key limits on the FDA's role and what we are not authorized to do.

FDA generally does NOT regulate the practice of medicine. While we can make sure that manufacturers provide doctors with the information they need to write a prescription, we cannot dictate what that prescription will be. The prescribing decision is that of the physician, using his or her medical judgment and knowledge about the individual needs of each patient.

Despite these limits, over the last decade or so FDA has worked hard, within the laws and regulations that we have, to address the misuse and abuse of prescription painkillers. We have accomplished some important things, yet we can and must do more — and indeed we will.

We have pursued a targeted, science-based, multi-pronged approach that addresses misuse, abuse and addiction at critical points in the lifecycle of an opioid product. This comprehensive approach includes encouraging both basic research about the science surrounding pain, and the development of more effective and appropriate treatment. We need new, better, safer treatment strategies for pain...and we need more effective strategies for the treatment of addiction itself. Our comprehensive approach also includes the development of abuse-deterrent drug formulations; scrutinizing opioid labeling for clarity and accuracy; considering ways to further prescriber and patient education; addressing innovative ways to package and store opioids to prevent diversion, and finally improving the availability of products that treat abuse and overdose.

Our approach must begin with science, and be grounded in our understanding of human biology and the mechanisms of disease, pain and its treatment. We recognize the active, ongoing debate over whether opioids should be used to treat patients with chronic, non-cancer pain — and, if so, whether prescribing information for these patients should be revised. At FDA, and amongst many of our colleagues, there is a strong feeling that more data is needed to address these questions that matter so much to patients, their families, their health care providers, and our communities. That's why we held a joint meeting with the National Institutes of Health last May on the efficacy of opioids in treating this class of patients and that's why we are working with academics and other scientists to discuss clinical trials that could study these types of issues.

The primary tool that FDA uses to inform prescribers about the approved uses of medications is the approved product label. This is what many call the package insert, often a folded paper put inside the drug carton. The information provided in the drug label is based on a variety of scientific and clinical information gathered about the drug, including clinical pharmacology studies, animal studies, clinical studies and postmarket experience.

FDA has made many changes to opioid medication labels in an effort to improve their use, and today they contain some of the most restrictive language that can be found in a drug label.

Having said that, there has been a call for further limitations on the use of these products, particularly in the context of non-cancer pain — including limiting the recommended duration of treatment; setting a maximum daily dosage limit; and restricting the use of these drugs to patients with severe pain (as opposed to "moderate to severe" pain). But if additional improvements could make the labels more effective, it's important we explore them as part of our overall efforts to improve the safety of opioids. We recently held a public meeting to get input on opioids labeling and we're currently considering what changes might be useful.

We are listening hard to the many issues and concerns. In February of this year, our Agency convened a public meeting during which we asked experts for input on what data already exist to support further labeling changes, and solicited stakeholder recommendations on potential labeling changes. We are currently reviewing that information, and we will share the outcome of our review as soon as it's completed.

We know that one of the key scientific issues today is the development of opioids that are specifically formulated to deter abuse. Abuse-deterrent formulations target the known or expected routes of abuse, such as crushing a long-acting opioid in order to release the active ingredient more quickly, generally for inhalation or injection.

FDA considers the development of abuse-deterrent formulations to be a clear and pressing public health priority, and we are committed to incentivizing and facilitating further development of this approach. In January of this year, we issued a Draft Guidance to assist industry in developing abuse-deterrent opioids. The Draft Guidance announced a new framework for categorizing abuse-deterrent characteristics and explains the types of testing and data that we would expect to see in order for a specific product to obtain abuse-deterrence labeling. If you look at the guidance, you will see that FDA intends to take a flexible, adaptive approach to the evaluation and labeling of potentially abuse-deterrent products. We are very eager to get input on our approach.

This guidance will be discussed at a two-day meeting on Sept. 30 and Oct. 1, co-sponsored by the Cross — Company Abuse Liability Consortium (CCALC) and the College on Problems of Drug Dependence (CPDD). FDA will be an active participant and we are looking forward to the dialogue.

While abuse deterrence holds much promise, the science of abuse deterrence is relatively new, and both the formulation technologies and the analytical, clinical, and statistical methods for evaluating those technologies are rapidly evolving. And we all know from sad experience that sometimes it is just a matter of time before those who are dedicated to abusing an opioid will find a way to do so even if it requires overcoming the latest abuse-deterrent technology. Given these issues, it is essential that every abuse-deterrent claim be grounded in science...and that they really work. This means FDA's staff of experts must conduct a scientific assessment of the data demonstrating that a product truly has abuse-deterrent qualities.

Of late, there has been much interest in whether FDA can take action regarding generic versions of opioid drugs when new formulations that are intended to be abuse-deterrent come on the market. The answer is yes. We have concluded that, if FDA finds a new formulation to be abuse deterrent, then the Agency has the legal authority under the Food, Drug and Cosmetic Act to require that generic versions of that product have abuse-deterrent formulations as well. In addition, under certain circumstances, we believe that we would have the authority to refrain from approving non-abuse deterrent formulations of that drug and to initiate procedures to withdraw non-abuse deterrent versions already on the market.

But for the reasons I just explained — and as you will see if you read our Draft Guidance on development of abuse-deterrent products — whether a product actually has abuse-deterrent qualities is not straightforward. Thus, FDA must independently analyze each case — each claim - and make a scientific determination about whether the new formulation is abuse-deterrent.

We have also received inquiries about specific opioid drug products and whether the Agency believes that those products are, in fact, abuse-deterrent. FDA's scientific staff is actively reviewing the data relating to specific opioid products. I understand that some of you were hoping that FDA might announce decisions about our assessment of those data today...and frankly that had been my hope too. Unfortunately, we're not ready to do that, but I can report that we expect to do so soon.

And we will continue to seek ways to spark further innovation in this critical and burgeoning area of research, innovation and development. It is our hope that the meeting on our Draft Guidance in September will include a robust discussion about ways to incentivize new and more effective abuse-deterrent formulations, and we are pursuing other strategies as well.

Let me now briefly discuss FDA's work on the Risk Evaluation and Mitigation Strategy, or REMS for extended-release (ER) and long-acting (LA) (ER/LA) opioid products. As the opioid epidemic has evolved in recent years, these products have demonstrated a very high potential for harm, misuse, and abuse. These drugs include extended-release and long-acting versions of such well-known brands as Oxycontin and Opana. They contain large amounts of opioids in a single dosage form, sometimes in sufficient quantity to be lethal, especially in children, and they are a prime target of drug abusers.

In July of last year, after a three-year effort, FDA implemented a REMS for manufacturers of over 20 extended-release and long-acting opioids. This REMS acknowledges that our nation's front-line health care professionals play an important role in efforts to reduce the abuse and misuse of opioids.

But it is also critically important to improve prescribers' knowledge about the best uses of opioids, including knowing when these products should be used and by which patients.

Thus prescriber education is an important element of this REMS for long acting and extended release opioids. Under the opioid REMS, manufacturers are required to ensure that prescriber training programs — offered by accredited continuing education provider — are made available for all U.S. licensed prescribers, using a syllabus developed by FDA with input from many stakeholders.

The first of these voluntary prescriber training programs was rolled out on March 1st, and others will soon follow.

Although these courses are voluntary, not mandatory, for prescribers, we are working hard to spur participation. Voluntary training is important, but, in my view, ultimately mandatory training is essential. That is why we support legislation to require that prescribers undergo training on responsible opioid prescribing practices before they can register with the Drug Enforcement Agency and receive their license to prescribe a controlled substance.

Not only is prescriber training absolutely necessary, but so too is adequate patient education. That's why it's part of the REMS for long acting and extended release opioids as well. And why FDA is also partnering with the National Council on Patient Information and Education in a patient education campaign aimed at teenagers and college students.

We also recognize that diversion of prescription opioid products is a huge problem. To address this issue, we are currently interested in exploring whether innovative package or storage designs for opioids can prevent or deter misuse and abuse.

FDA is also looking at whether to expand the options for patients who overdose — we know what a serious problem it is. Emergency medical personnel are trained to administer naloxone, an injectable medicine that can rapidly reverse an opioid overdose. This medicine can save lives, but it needs to be administered promptly. We know there is widespread interest in exploring the broader uses of this product. We are currently encouraging new technology, such as intranasal or autoinjector formulations, that would be easier to use in non-medical settings, such as the home.

I want to leave time for broader discussion and Q and A, so I will draw to a close, though there is so much more to talk about and explore.

Today I've tried to outline some of what FDA is doing to address opioid abuse, misuse and addiction, in keeping with our public health mission...and our commitment to protect and promote the health of the American people. There can be no doubt that there is much to be done...and we must act now. These are not simple issues and there are no easy answers. Given the complexity of the issues surrounding the abuse, misuse and addiction to prescription painkillers, real and enduring progress will require dedication, persistence and the full engagement of all parties. And we must share a sense of urgency. And towards this end, one more thing is clear: organizations like Operation UNITE — and meetings like this one — are making a difference. Your leadership and your firm commitment to meaningful dialogue and cooperation in addressing the prescription drug abuse epidemic, that so plagues our nation, our communities and our families, will make a real and enduring impact. We welcome the opportunity to work with you, to partner with all of you, as individuals and organizations, and, together, to turn the tide on this devastating epidemic.

Thank you.